SPIKEVAX
STN: 125752
Proper Name: COVID-19 Vaccine, mRNA
Tradename: SPIKEVAX
Manufacturer: Moderna Tx, Inc
Indication:
- For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
Product Information
- Package Insert - SPIKEVAX
- Patient Package Insert - SPIKEVAX
- Demographic Subgroup Information – COVID-19 Vaccine, mRNA (SPIKEVAX).
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- September 6, 2024 Approval Letter - SPIKEVAX
- August 22, 2024 Approval Letter - SPIKEVAX
- April 19, 2024 Approval Letter - SPIKEVAX
- September 11, 2023 Approval Letter - SPIKEVAX
- September 11, 2023 Clinical Review - SPIKEVAX
- September 11, 2023 Statistical Review - SPIKEVAX
- May 9, 2023 Approval Letter - SPIKEVAX
- January 31, 2022 Approval Letter - SPIKEVAX
- January 30, 2022 Summary Basis for Regulatory Action - SPIKEVAX
- Approval History, Letters, Reviews, and Related Documents - SPIKEVAX
Spikevax Safety and Effectiveness FAQ